The AQUARIUS 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the AQUARIUS 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only.

The AQUARIUS 8600 is not intended for mammography.

Device Description

The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes with a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

AI/ML Overview

This is a 510(k) premarket notification for the AQUARIUS 8600 Digital Radiography Sensor. The core of this submission is to demonstrate the substantial equivalence of the modified device to a previously cleared predicate device.

Based on the provided text, the acceptance criteria and the study proving the device meets those criteria are established through a non-clinical performance evaluation and image comparison rather than a human-in-the-loop clinical trial or a detailed algorithm performance study with predefined metrics like sensitivity/specificity. This is typical for certain types of device modifications or new devices where the primary claim is equivalence in image quality or basic functionality to an existing device.

Here's the breakdown of the information requested, based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical performance thresholds (e.g., specific sensitivity, specificity, or image quality scores). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices in terms of:

Acceptance Criteria Category	Reported Device Performance and Justification
Image Quality and Characteristics	"The Aquarius 8600 produces images of similar quality and characteristics that are equivalent to those of the both the Aquarius 8600 and BIOK4600 predicate devices."
Hardware Performance	"Because the sensor hardware is the same as the Aquarius 8600 predicate device hardware, the sensor has the same performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device."
Software Functionality	"The Aquarius 8600 software functionality is equivalent to the original BIOK4600 predicate device, except for the Sensor Driver interface application which reads the images from the Aquarius 8600 flat panel instead of the BIOK 4600 sensor."
Conformity to Standards	"The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems."
Technical Specifications (Physical/Operational)	Spatial resolution: 3.9 lp/mmOptical resolution: 3.9 lp/mmAcquisition to display time: < 2 secNetwork interface: 1000 mbps LANImage and file formats: DICOM compliantPower: 24Vdc, 1.9A max (18W typ)These specs implicitly met by equivalence to predicate.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document mentions "Test images have been submitted along with the equivalent images from the Aquarius 8600 predicate device." However, it does not specify the number of images or cases in this test set.
Data Provenance: The provenance (country of origin, retrospective/prospective) of these "test images" is not specified in the provided text. It's likely that these were images generated internally or from previous testing since the hardware is effectively the same as a predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not mention the use of experts in a formal ground truth establishment process for a test set. The assessment appears to be based on a direct comparison of physical image attributes and technical specifications against the predicate devices, rather than a clinical interpretation by experts.

4. Adjudication method for the test set

Given that formal expert review to establish ground truth is not mentioned, there is no stated adjudication method. The comparison seems to be based on the manufacturer's internal assessment of image similarity and technical equivalence.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done or reported. This device is a digital radiography sensor (hardware and basic image acquisition/processing software), not an AI-powered diagnostic aid for interpretation. Therefore, the concept of human readers improving with AI assistance is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A "standalone" algorithm performance study in the sense of sensitivity, specificity, and other performance metrics calculated by an algorithm on a dataset was not performed or reported. The evaluation focused on the technical equivalence of the image acquisition system to previously cleared devices. The "algorithm" here is primarily within the proprietary processing software for image acquisition and digitization, not a diagnostic AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically used for AI diagnostics (e.g., for disease detection) is not applicable here. The "ground truth" in this context is implicitly the established performance and image characteristics of the predicate devices. The new device is considered "equivalent" if its images and functionality align with what the predicate devices produce.

8. The sample size for the training set

This device is not an AI algorithm that undergoes "training" on a dataset in the typical machine learning sense. It's a digital radiography sensor with associated image processing software. Therefore, there is no concept of a training set in the provided document.

9. How the ground truth for the training set was established

As there is no training set for this type of device, this question is not applicable.

Summary

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July 13, 2018

Biokinemetrics Inc. % Steven Kraus President 211 East 4th Street CARROLL IA 51401

Re: K181565

Trade/Device Name: AQUARIUS 8600 Digital Radiography Sensor Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: June 13, 2018 Received: June 14, 2018

Dear Steven Kraus:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Hol 2. Nils

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181565

Device Name AQUARIUS 8600 Digital Radiography Sensor

Indications for Use (Describe)

The AQUARIUS 8600 is not intended for mammography.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Biokinemetrics. The logo is in blue and green, with the word "BIOKINE" in blue and "METRICS" in green. Below the logo is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in a smaller blue font. The logo is simple and modern, and the tagline is clear and concise.

SPECIAL 510K - SUMMARY OF SAFETY AND EFFECTIVENESS

1. Device type and name: Aquarius 8600 Digital Radiography Sensor Common name: Aquarius 8600
1. Submitter Biokinemetrics Inc. 211 East 4th Street Carroll lowa 51401
- Contact person: Dr. Steven Kraus President Tel: (712) 210-4750 Fax: (888) 800-2149 e-mail: skraus@biokinemetrics.com

June 12, 2018 Date prepared:

1. Device classification: 21 CFR 892.1680, Stationary x-ray system
1. Product Code: 90/MQB
1. Basis for the submission: Software modifications to support Aquarius 8600 Flat Panel Detector.
1. Predicate devices: Primary: Aquarius 8600 Flat Panel Detector (K170202) For the ChiroSight software: BIOK4600 Digital Radiography Sensor (K092307) *same classification & product code: 21 CFR 892.1680, 90/MQB, KPR
1. Device description: The Aquarius 8600 is a digital radiography sensor which automatically collects x-ray images from an x-ray source. The Aquarius 8600 sensor (flat panel type) collects x-rays and digitizes the images for their transfer and display to a computer. The sensor does not have an x-ray source, which is provided by independent manufacturers. The sensor includes with a flat panel for x-ray acquisition and digitization and a computer (including proprietary processing software) for processing, annotating and storing x-ray images.

An x-ray generator with a minimum voltage output range between 55 to 120 kVp and a minimum power of 30 KW can be used with the Aquarius 8600. The Aquarius 8600 does not connect to the generator. It automatically detects x-rays and enables the image acquisition. No changes to the generator hardware or software are required to operate the Aquarius 8600.

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Image /page/4/Picture/0 description: The image shows the logo for Biokinemetrics. The logo is in blue and green, with the word "BIOKINEMETRICS" in large, bold letters. Below the word is the tagline "ALIGNING CHIROPRACTIC AND TECHNOLOGY" in smaller letters. The logo is simple and modern, and it conveys the company's focus on chiropractic and technology.

1. Indications for use: The Aquarius 8600 is intended for use by a qualified doctor or technologist on both adult and paediatric patients for taking diagnostic radiographic exposures of all body parts of the patients. The Aquarius 8600 provides digital image capture and is intended to replace radiographic film/screen. The x-ray generator, x-ray tube and associated equipment are not provided with the proposed sensor. Prescription use only. The Aquarius 8600 is not intended for mammography.
1. Comparison with predicate devices: The Aquarius 8600 is composed of the Aquarius 8600 predicate device hardware and the BIOK4600 software on the PC. The hardware and firmware of the Aquarius 8600 flat panel is UNMODIFIED and is considered to be substantially equivalent to the Aquarius 8600 predicate device hardware. The Aquarius 8600 software functionality is equivalent to the original BIOK4600 predicate device, except for the Sensor Driver interface application which reads the images from the Aquarius 8600 flat panel instead of the BIOK 4600 sensor. The Aquarius 8600 produces images of similar quality and characteristics that are equivalent to those of the both the Aquarius 8600 and BIOK4600 predicate devices.
- a. Non-clinical tests: Because the sensor hardware is the same as the Aquarius 8600 predicate device hardware, the sensor has the same performance, biocompatibility, effectiveness, thermal, electrical and mechanical safety and is substantially equivalent to the predicate device. The design, development and production of the sensor conforms to 892.1680 and ISO 13485 quality systems.
- b. Image Comparison: Test images have been submitted along with the equivalent images from the Aquarius 8600 predicate device.
- C. Conclusion: the device was evaluated against both predicate devices (BIOK4600 and Aquarius 8600) and was found to be substantially equivalent to the predicate devices.

X-Ray Equipment(Generator, Tube)	Not provided by Biokinemetrics
Flat Panel Sensor	AQUARIUS 8600 Flat PanelDetector array size: 17" x 17"(423mm x 423mm)TFT matrix: (3328 x 3328 pixels)
Flat Panel Sensor	Spatial resolution: 3.9 lp/mmOptical resolution: 3.9 lp/mmAcquisition to display time: < 2 secNetwork interface: 1000 mbps LANImage and file formats:DICOM compliantPower: 24Vdc, 1.9A max (18W typ)
PC	Dell Optiplex 7050, small form factor128GB SSD + 2TB HDD8GB memoryFull HD video capabilityHDMI, DisplayPort outputi5 or i7 intel CPU (or equivalent)2x LAN connections (10/100/1000)
PC software:	ChiroSight software

1. Technological Characteristics:

Regulation Number and Section

N/A